Congress: Drop Sec. 716 — FDA Exemption — From NDAA

The 2018 National Defense Authorization Act contains billions of dollars and much policy concerning medical research and, of course, matters relating to nuclear, biological and chemical warfare. We don’t cover most of those medical issues except when they relate to NBC issues or raise basic military policy considerations. This is one of those cases. In this commentary, the distinguished medical ethicist and professor at the University of Pennsylvania, Jonathan Moreno, calls on Congress to scrap a provision in the 2018 NDAA concerning emergency medical exemptions from FDA oversight. Read on! The Editor.

The final draft of the National Defense Authorization Act would give the Pentagon authority to decide when unapproved drugs and devices (called somewhat vaguely “agents of war” in the proposed legislation), could be used on military personnel in an emergency. Historical experience suggests that this is a very bad idea that would create both medical and morale problems for the military and obscure the difference between medical intervention and experimentation.

This proposal should be dropped from the legislation.

Those who support the new rules complain that they have to enter into continuing discussions with the Food and Drug Administration (FDA) while potentially useful drugs and other materials are given temporary approval. No doubt careful information gathering can be frustrating. But it is also the only way to know that something isn’t harmful and might actually help. The history of civilian and military medicine is full of examples of presumed therapies that turned out to be useless or caused harm.

The FDA is the only government agency authorized to approve drugs and devices for prevention and treatment. Under the proposed rule change the Defense Department would be the first federal agency that would have a separate regulatory system, a dangerous and needless precedent for all concerned. The FDA and the DoD have long worked together to make it possible for commanders to get unapproved drugs and devices to troops. This system both allows the FDA to weigh in with its expertise on potential risks and benefits – information that commanders would surely want to have in case after using the stuff things go south – and provides a degree of “cover” to the Pentagon in case there are complaints later on. As there surely would be.

Consider the experience with unapproved drugs in Desert Storm/Desert Shield (DS/DS). As the Pentagon was preparing for the invasion of Kuwait in 1990, it received reports that Saddam Hussein had stores of several biological and chemical agents and the ability to deliver them. The available treatments and preventions for these agents were speculative to varying degrees. For instance, the botulism toxin (BT) vaccine was considered “investigational” by the FDA. DoD petitioned the FDA commissioner for a waiver of the usual informed consent requirement, noting the therapeutic potential of the treatments against threats to the force. The FDA then adopted a rule that allowed the commissioner to drop the consent requirement in combat situations when such consent was “not feasible.”

Even this arrangement mainly stated what has already long been understood. Military medical ethicists and regulators agree that although people in uniform cannot be ordered to be in an experiment – a view that only emerged after World War II – commanders may justifiably order the use of drugs or devices that do not have demonstrated safety and efficacy if they believe that their force is under imminent threat and that their use is the best option. In turn, people in uniform will accept pretty much anything that is in the line of duty, especially if it will help them protect their brothers and sisters in arms, but they understandably resent being used as “human guinea pigs” as much as anyone else.

Problems of data collection, so crucial to gaining knowledge of drug effects, are severe enough in a carefully planned peacetime context of clinical trials. During a shooting war these problems are far greater as the confusion of combat conditions affects the way drugs are given and taken. Record keeping for the drugs that were used in Desert Storm and Desert Shield was poor even though logisticians could have helped gather information useful in future deployments. Perhaps 8,000 troops received the BT vaccine in the weeks before the invasion of Kuwait. Another 150,000 or so were vaccinated for inhalational anthrax. Tens of thousands received blister packs of a theorized antidote to nerve gas called pyridostigmine bromide (PB), used to treat myasthania gravis, a disease that progressively weakens muscles. The use of PB was voluntary but many thought it was required. The Pentagon had in fact tested PB on a few dozen personnel, not including those who might be sensitive to the drug or women, but those people were not excluded when the drug was given out.

In the months and years after the first Gulf War, veterans complained that their medical problems, often grouped under the term Gulf War Illness, were due partly to the drugs they were given. The etiology of this set of symptoms has never been fully understood but the anger can’t be questioned. Among the earliest Internet list serves were those of Gulf War veterans expressing their resentment. Over the years, I have been approached by many vets complaining about their medical conditions and the fact that records aren’t available, a concern that was echoed by a VA lawyer in a conversation I had just a few weeks ago.

Ironically, the FDA gave the Pentagon an opportunity to avoid much of the later anger by issuing their waiver on the condition that military personnel receive information about what they were being ordered or asked to take. That didn’t happen. In 1994 some members of Congress expressed their annoyance at the civilian agency for granting the waiver in the first place (though the FDA noted that it’s not expert at fighting wars), and then for not complaining to the DoD that they failed to uphold their side of the deal. So, in the end, the civilian agency got it from both ends, which actually took some heat off the Pentagon. This is a story I told in my book, Undue Risk.

Going back to the 1950s the Department of Defense has a mixed record on human experiments, but the FDA’s evolved role in drug and device approval gives our military organization a substantive argument that it takes respect for the troops seriously. It’s too bad that the Pentagon can’t take yes for an answer.

Studies Yield Clues to Roots of Gulf War Illness

Presentations at the Society for Neuroscience meeting point to changes in neurons and connectivity between brain regions as potential components of the enigmatic condition.

By Shawna Williams | November 13, 2017

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ISTOCK, KARENFOLEYPHOTOGRAPHYCombat in the Gulf War of 1990-91 lasted less than two months, but it’s estimated that hundreds of thousands of the troops who served in the Middle East during that time may still experience symptoms of Gulf War Illness (GWI). Thought to be caused by exposure to chemical and biological weapons or other hazardous chemicals, GWI’s symptoms include difficulties with memory and speech, mood swings, and chronic pain.

Two studies presented at the annual Society for Neuroscience Meeting on November 11 and 14 provide some clues to GWI’s biological basis. The first, described by Anika Patil of Drexel University College of Medicine, treated cultured rat neurons with a sarin gas analogue, and found it led to the deacetylation—and destabilization—of the cells’ microtubules, which are needed to transport mitochondria and other cellular components. Pretreating the cells with corticosterone to mimic the effects of stress exacerbated the effect. For deployed service members, “there is an ongoing stress from the moment you leave until the moment you return,” commented Col. Deborah Whitmer of Walter Reed Army Institute of Research, who moderated a press conference about the findings.

In another study discussed at the press conference, Kaundinya Gopinath of Emory University and colleagues compared the resting state fMRI scans of 22 Gulf War veterans with those of 30 controls, and found that the veterans had less neural communication in areas associated with visual and other sensory processing, mood regulation, language, and motor coordination, but more activity in pain perception networks. “The results from this study provide strong evidence of neuropathology in GWI patients from exposures to neurotoxic agents,” Gopinath says in a statement, adding that finding brain mechanisms to explain that pathology could lead to treatments.

(91outcomes.com) - Newly published research results show a clear link between higher chemical exposures during the 1991 Gulf War and increased cognitive and mood symptoms among veterans of that war.The study included extensive interviews and examinations of "159 Gulf War-deployed preventative medicine personnel who had varying levels of pesticide exposures during their work as pesticide applicators or other preventative medicine roles". According to the study's publication, "Study results showed that the participants with both high pesticide and high [Nerve Agent Protective Pill (PB)] exposure performed worse on specific measures than the groups with high single exposures or low exposures to both toxicants." Study results showed that "high combined exposure was associated with significantly slower information processing reaction times, attentional errors, worse visual memory functioning, and increased mood complaints. In addition, ... analyses of individual pesticide exposures found that pest strip exposure was associated with slower reaction times and attentional errors, and that fly bait and delouser exposures predicted greater mood complaints."The chemicals involved affect brain chemistry and, "are known to produce chronic health and cognitive symptoms at sufficient exposure levels," according to earlier research cited in the study. The chemical warfare nerve agents Sarin and Cyclosarin -- acknowledged to have been released at the Khamisiyah munitions depot demolitions immediately following the war's ceasefire -- are in the same class of chemicals (Organophosphates, or OP's) as some of the pesticides analyzed in this study. This extensive, multi-year research project was funded by a Fiscal Year 2006 grant from the Gulf War Illness Research Program (GWIRP), part of the Congressionally Directed Medical Research Program (CDMRP) funded by Congress within the Defense health program. The study's principal investigator was Dr. Kimberly Sullivan of the Department of Environmental Health with the Boston University School of Public Health. Dr. Sullivan currently leads a major Gulf War Illness treatment development Consortium, which is also funded by the CDMRP. This treatment development study is currently recruiting both healthy Gulf War veterans and those with Gulf War Illness at its study sites in Boston, Miami, and Houston. More information about the ongoing Gulf War Illness treatment development study is available at: http://sites.bu.edu/gwic .

-91outcomes

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Study Highlights

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Gulf War Veterans (GWV) were exposed to pesticides and pyridostigmine bromide (PB) pills during the war.

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We compared cognitive and mood functioning in GWV who were pesticide applicators or non-applicators during the war.

Abstract

1991 Gulf War (GW) veterans continue to experience debilitating cognitive and mood problems more than two decades following their return from deployment. Suspected causes for these cognitive complaints include additive and/or synergistic effects of the varying combinations of exposures to chemicals in theater, including pesticides and pyridostigmine bromide (PB) pills. This study was undertaken to address one of the key recommendations of the US Department of Defense Environmental Exposure Report on Pesticides, which was to conduct an epidemiological study to further evaluate the role of neurotoxicant exposures in the expression of central nervous system symptoms reported by GW veterans. This study evaluated the role of pesticides and/or PB in the development of chronic neuropsychological dysfunction in GW veterans. We examined the associations between self-reported measures of pesticide and PB exposures and performance on neuropsychological tests in a group of 159 GW-deployed preventative medicine personnel who had varying levels of pesticide exposures during their work as pesticide applicators or other preventative medicine roles. These veterans had a unique knowledge of pesticides and their usage during the war. It was hypothesized that pesticide applicator personnel with higher exposures would perform significantly worse on objective cognitive measures than lower-exposed personnel and that multiple chemical exposures (pesticide and PB) would further diminish cognitive functioning and increase mood complaints. Study results showed that the participants with both high pesticide and high PB exposure performed worse on specific measures than the groups with high single exposures or low exposures to both toxicants. High combined exposure was associated with significantly slower information processing reaction times, attentional errors, worse visual memory functioning, and increased mood complaints. In addition, stepwise regression analyses of individual pesticide exposures found that pest strip exposure was associated with slower reaction times and attentional errors, and that fly bait and delouser exposures predicted greater mood complaints.

Acknowledgements

This study was funded by a grant from the Department of Defense (W81XWH-04-1-0118). The opinions or assertions contained herein are the private views of the author(s) and are not to be construed as official or as reflecting the views of the Department of Veterans Affairs, Army or the Department of Defense. We'd also like to acknowledge the DOD Force Health Protection and Readiness office for their assistance with providing the EER-pesticides report telephone interviews and PCI information. We also wish to thank the veterans who took the time to participate in this study.

Dr. Dane Cook is a professor of kinesiology at the University of Wisconsin-Madison and a health scientist and research physiologist at the William S. Middleton Memorial Veterans Hospital. (Photo courtesy of UW)

A study from the Madison VA Hospital in Wisconsin has shown that structural damage in the white matter of the brain may be linked to chronic musculoskeletal pain in Gulf War Veterans.

Using magnetic resonance imaging, the researchers found that participants with chronic pain had widespread disruptions in the structure of their white matter across several regions of the brain. White matter is deep tissue within the brain that contains axons, nerve fibers that conduct electrical signals and connect different areas of the brain. Many of the brain regions found to be affected in the study are involved in the interpretation of pain stimuli and the emotional aspects of pain perception.

The results showed that poorer white matter health was linked to higher pain levels. It was also connected with higher levels of fatigue and, to a lesser extent, depression. In the words of the researchers, “These data suggest that poor white matter health may contribute to the persistent widespread pain that is experienced by a significant number of Veterans who were deployed to the Persian Gulf.”

According to Dr. Dane E. Cook, corresponding author on the article, results such as these can provide objective evidence of a person’s subjective experience. He explains, “Changes in brain white matter show that there is something wrong in the central nervous system that may explain why the Veteran is experiencing widespread pain.”

Chronic pain common in Gulf War Vets

"Changes in brain white matter show that there is something wrong in the central nervous system that may explain why the Veteran is experiencing widespread pain."

Chronic musculoskeletal pain affects around 25 percent of Veterans who were deployed during the Persian Gulf War. It is one of the cardinal symptoms of Gulf War illness, a chronic condition with a variety of symptoms that is largely medically unexplained. Veterans deployed to Iraq and Afghanistan more recently as part of operations Enduring Freedom and Iraqi Freedom have also shown similar rates of chronic musculoskeletal pain.

The patients in the Madison VA study with chronic pain also had lower quality of life and physical functioning than those without chronic pain, according to assessments given to each participant.

Evidence has suggested that Gulf War illness symptoms are related to structural changes in the brain. A 2008 report by the VA Research Advisory Committee on Gulf War Veterans’ Illnesses linked decreased white matter volume to Gulf War illness. In the new study, the researchers were looking for brain structural damage specifically linked to pain. To do so, they recruited 30 Veterans with chronic musculoskeletal pain from operations Desert Storm, Desert Shield, and Iraqi Freedom. They also tested 31 Veterans of these conflicts without chronic pain, for comparison.

The researchers took MRIs of each participant’s brain. They used a technique called diffusion tensor imaging to study the spread of water through the brain. Water tends to diffuse along the direction of the axons, the researchers explain, meaning that MRI can be used to map the structural integrity of white matter. One study by Georgetown University researchers was able to tell the difference between patients with Gulf War illness and those without by using diffusion mapping.

The disruptions in water diffusion found in the Madison VA study suggest that the myelin structure of axons is impaired in those with chronic pain, write the researchers. Myelin is a material that surrounds axons and nerve cells. It serves as an electrical insulator and allows the nervous system to function properly.

VA RESEARCH TOPIC PAGES

Central nervous system affected

Finding disruptions in white matter that are significantly related to the experience of pain is an important step towards determining the mechanisms of chronic pain in Gulf War Veterans, explains Cook. The findings “emphasize that chronic pain in Gulf War Vets and perhaps Gulf War illness affects the central nervous system.” Other chronic pain conditions and diseases are categorized as central nervous system diseases, but Gulf War illness is less well understood. Figuring out how Gulf War illness affects the central nervous system and causes pain can help doctors understand and treat the condition.

According to the researchers, the results could aid in testing and treatments designed to improve brain health. Understanding the connection between white matter damage and pain could lead to new testing and treatment techniques. However, they explain, “what is yet to be determined is whether these microstructural relationships are reversible with appropriate treatment, and whether changes in white matter structure will lead to improvements in symptoms.”

The next step, says Cook, is to test whether treatments aimed at relieving pain also change the white matter. The research team is in the final year of a clinical trial using exercise training as a treatment for Veterans with chronic pain. They are assessing both pain symptoms and white matter over time to test whether changes in white matter are related to changes in pain. Cook hopes that this ongoing study could lead to better treatments for chronic pain: “Our premise is that by targeting potential mechanisms of disease maintenance, we will be better able to target our treatments, a form of personalized medicine.”

(91outcomes.com) A new research study out of Georgetown University adds further evidence to a growing body of research that suggests that Gulf War Illness is a diagnosable health condition distinct from Chronic Fatigue Syndrome and other health disorders. This research was funded by the treatment-focused Gulf War Illness Research Program within the DoD Congressionally Directed Medical Research Program (cdmrp.army.mil/GWIRP), and the Sergeant Sullivan Center, Dr. Barbara Cottone, Dean Clarke Bridge Prize, and the National Institutes of Health National Institute of Neurological Diseases and Stroke.The diagnostic technology has been patented by the researchers. -91outcomes*****

WASHINGTON -- Researchers at Georgetown University Medical Center have found distinct molecular signatures in two brain disorders long thought to be psychological in origin -- chronic fatigue syndrome (CFS) and Gulf War Illness (GWI).

In addition, the work supports a previous observation by GUMC investigators of two variants of GWI. The disorders share commonalities, such as pain, fatigue, cognitive dysfunction and exhaustion after exercise.

Their study, published in Scientific Reports, lays groundwork needed to understand these disorders in order to diagnosis and treat them effectively, says senior investigator, James N. Baraniuk, MD, professor of medicine at Georgetown University School of Medicine. Narayan Shivapurkar, PhD, assistant professor of oncology at the medical school worked with Baraniuk on the research.

The changes in brain chemistry -- observed in levels of miRNAs that turn protein production on or off -- were seen 24 hours after riding a stationary bike for 25 minutes.

"We clearly see three different patterns in the brain's production of these molecules in the CFS group and the two GWI phenotypes," says Baraniuk. "This news will be well received by patients who suffer from these disorders who are misdiagnosed and instead may be treated for depression or other mental disorders."

Chronic fatigue syndrome affects between 836,000 and 2.5 million Americans, according to a National Academy of Medicine report. The disorder was thought to be psychosomatic until a 2015 review of 9,000 articles over 64 years of research pointed to unspecified biological causes. Still, no definitive diagnosis or treatment is available.

Gulf War Illness has developed in more than one-fourth of the 697,000 veterans deployed to the 1990-1991 Persian Gulf War, Baraniuk and his colleagues have reported in earlier work.

Gulf War veterans were exposed to combinations of nerve agents, pesticides and other toxic chemicals that may have triggered the chronic pain, cognitive, gastrointestinal and other problems, Baraniuk says. Although the mechanisms remain unknown, the study provides significant insights into brain chemistry that can now be investigated.

This study focused on spinal fluid of CFS, GWI and control subjects who agreed to have a lumbar puncture. Spinal taps before exercise showed miRNA levels were the same in all participants. In contrast, miRNA levels in spinal fluid were significantly different after exercise. The CFS, control and two subtypes of GWI groups had distinct patterns of change. For example, CFS subjects who exercised had reduced levels of 12 different mRNAs, compared to those who did not exercise.

The miRNA changes in the two GWI subtypes add to other differences caused by exercise. One subgroup developed jumps in heart rate of over 30 beats when standing up that lasted for two to three days after exercise. Magnetic resonance imaging showed they had smaller brainstems in regions that control heart rate, and did not activate their brains when doing a cognitive task. In contrast, the other subgroup did not have any heart rate or brainstem changes, but did recruit additional brain regions to complete a memory test. The two groups were as different from each other as they were from the control group.

Finding two distinct pathophysiological miRNA brain patterns in patients reporting Gulf War disease "adds another layer of evidence to support neuropathology in the two different manifestations of Gulf War disease," he says.

Baraniuk adds that miRNA levels in these disorders were different from the ones that are altered in depression, fibromyalgia, and Alzheimer's disease, further suggesting CFS and GWI are distinct diseases.

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The study was supported by funding from The Sergeant Sullivan Center, Dr. Barbara Cottone, Dean Clarke Bridge Prize, Department of Defense Congressionally Directed Medical Research Program (CDMRP) W81XWH-15-1-0679, and National Institute of Neurological Diseases and Stroke R21NS088138 and RO1NS085131.

Baraniuk and Shivapurkar are named as inventors on a patent application that has been filed by Georgetown University related to the technology described.

About Georgetown University Medical Center

Georgetown University Medical Center (GUMC) is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through MedStar Health). GUMC's mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing & Health Studies, both nationally ranked; Georgetown Lombardi Comprehensive Cancer Center, designated as a comprehensive cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization, which accounts for the majority of externally funded research at GUMC including a Clinical and Translational Science Award from the National Institutes of Health. Connect with GUMC on Facebook (Facebook.com/GUMCUpdate), Twitter (@gumedcenter) and Instagram (@gumedcenter).

Wisconsin veteran wants the VA to recognize his Gulf War service caused cancer.

Retired Staff Sergeant Rodney Dean Kerksieck talks about his military career, including service in Iraq during Operation Desert Storm and its effects on his current health while serving during the Gulf War. Tyler Rickenbach/USA TODAY NETWORK-Wisconsin

His doctor says his cancer is likely caused by what he was exposed to in the war. The U.S. government won't extend benefits.

MARSHFIELD - Rodney Kerksieck's Gulf War was short: January through March in 1991. During those three months, he fired thousands of 200-pound shells from an 8-inch howitzer as a gunner for the U.S. Army.

His unit supported Marine infantry as the Americans faced off against Saddam Hussein's army, including the infamous Republican Guards. They were an intense, dirty and violent three months.

Shortly after the Gulf War, the Spencer native left the regular Army but re-joined the National Guard, and he and his wife, Billee, and their children moved back home to central Wisconsin. When he retired in 2004 as a staff sergeant, he thought he had left the war behind.

Today, Kerksieck is gaunt and tired, in another fight for his life. He was diagnosed with colon cancer in 2015, and Kerksieck and his oncologist at Marshfield Clinic both believe the disease is a direct result from his service in Iraq.

In addition to fighting the disease, Kerksieck is locked in a bureaucratic battle with the Department of Veterans Affairs, the agency which oversees the benefits veterans receive. Kerksieck wants to be classified as disabled because of the disease and his service in Iraq. If he is, he is entitled to about $1,200 a month plus other benefits. If he should die, those benefits, which also include health insurance, will transfer to Billee.

Kerksieck's condition is dire. Since his diagnosis in 2015, he's undergone traditional treatments such a surgery, radiation and chemotherapy. Those efforts have done little to stop the cancer's spread. The disease is entrenched throughout his upper body.

A few weeks ago, Kerksieck was accepted to be part of a clinical study through the University of Wisconsin Carbone Cancer Center. He's now receiving cutting-edge immunotherapy treatments designed to marshal the body's own immune system to kill off the cancerous cells. He and his medical team can't be sure it will work, but he's hoping for a miracle.

Getting disability benefits tied to the Gulf War is a long shot, too. It's up to Kerksieck to prove that his cancer is a result of his war service. So far his attempts have been denied, despite the support of his oncologist and commanding officers he served under in Iraq.

A statue of a soldier inside Rodney Kerksieck's office, signifying his retirement from the Army National Guard. Taken on June 15, 2017 in Kerksieck's home in Marshfield, Wis. (Photo: Tyler Rickenbach/USA TODAY NETWORK-Wisconsin)

Soaked in oil

As Rod Kerksieck grew up in Spencer, he was always interested in the military. He joined the National Guard in 1984 when he was 17 years old. The 1985 graduate of Spencer High School went off to basic training the summer after he received his high school diploma.

It didn't take him long to realize he wanted to make a career out of the military.

"I knew it positively after basic training," the 50-year-old Gulf War veteran said. "I got a taste of it, and I liked it."

For the teen-aged Kerksieck, the Army offered a lot: discipline, reward for hard work, a chance to fire the largest, most sophisticated weapons in the world. Plus, being a U.S. Army soldier felt good: Even as a teen, Kerksieck felt a love of country and a call to serve it.

When he got his papers in 1990 calling his unit to the Middle East as the Americans and coalition forces were building up to push, Kerksieck and Billee were living in Washington State near Fort Lewis, where he was based. They had two children: Stephanie, who was about 3 years old, and their son Eric, who had been born just a few months before. The Army gave Kerksieck 72 hours to get his affairs in order and be on a plane to war.

He and his fellow soldiers flew out of McChord Air Force Base in Washington on a 747. They landed on a hastily built airfield somewhere in the desert in the northern part of Iraq, he said.

Kerksieck and the others were "fully geared up" for that landing, including holding their M16 rifles and wearing equipment designed to protect them in case of a poison attack.

The Gulf War started after Iraq invaded Kuwait in August 1990. When diplomatic efforts failed, the United States and a coalition of 34 other countries banded together to push the Iraqis out of Kuwait.

Once equipment and soldiers were ready for battle, Kerksieck's unit manned a massive howitzer cannon — 8 inches being the bore size of the gun. The gun's mission was to provide artillery support to Marine infantrymen. That included decimating Iraqi villages.

"We'd blow up everything," Kerksieck said. "I mean, if there was one wall standing, we'd blow it up. We completely leveled these places."

He estimates he fired 3,000 to 4,000 rounds, and he slept in a foxhole next to the howitzer. As Iraqi forces pulled away from the oil fields that peppered the northern region of Iraq, they set them on fire. Petroleum muck rained down on Kerksieck and the other Americans, and he constantly was breathing in the smoke. At the end of the days, he'd have to wash the oil off his skin.

The American soldiers also burnt their own debris in burning pits, including human waste, with fires started with diesel fuel.

As quickly as it began, it was over. The howitzer was sold to the Saudi military, he said. He and the men with whom he served were given new uniforms "so we would look good when we got back to the world," Kerksieck said.

They got on another jet airliner, and then they were home.

Retired Staff Sgt. Rodney Dean Kerksieck holds a folded American flag in his office on June 15, 2017, in his home in Marshfield, Wis. (Photo: Tyler Rickenbach/USA TODAY NETWORK- Wisconsin)

Burden of proof falls on vets

The system is stacked against Kerksieck and many other Gulf War veterans who try to collect disability payments related to the illnesses they've suffered in the wake of their war service.

In many ways, the rules and regulations of the VA, which works under the laws set by Congress, set up an adversarial relationship between the federal agency and the veterans it's charged to serve.

For some veterans suffering from certain illnesses, the process is simplified, said Rock Larson, the veterans service officer for Wood County. Larson's job is to help veterans negotiate through the Department of Veterans Affairs to get the benefits they deserve. He doesn't work for the VA, but he knows how the agency works.

The VA has classified some diseases as "presumptive." That means that if a veteran contracts that particular disease, it's presumed that his or her time in the service likely caused it. That streamlines the process to determine if disability benefits will be granted. Among presumptive diseases for Gulf War veterans are West Nile virus and a group of ailments commonly known as Gulf War Illness.

Colon cancer is not on that list of Gulf War presumptive illnesses. According to a VA spokesman, the reason some illnesses are not presumptive is that "medical science, which forms the basis of the laws, regulations and policies, has not found adequate evidence that the claimed disability is more likely than not connected" to veterans' service.

That means the burden falls to veterans to prove their nonpresumptive illnesses are service-related. The system leaves veterans such as Kerksieck battling for disability compensation often at the time when they are struggling the most with their disabilities.

The onus falls on veterans because "that is the way the law is written," according to the VA spokesman. "If you have questions regarding the laws governing VA disability compensation, we would refer you to Congress."

A 2008 study by the VA Research Advisory Committee on Gulf War Veterans' Illnesses estimates that related health complications affect "at least one fourth of the 697,000 U.S. veterans who served" in the 1990-1991 war.

A more recent report from The National Academies of Sciences, Engineering and Medicine concluded that Gulf War veterans "appear to have an increased risk for Gulf War illness, chronic fatigue syndrome, functional gastrointestinal conditions and mental health disorders." That study, completed in February 2016, was designed to pay particular to neurological disorders, cancer and Gulf War illness. It did not specifically mention colon cancer.

James Bunker is the executive director of the National Gulf War Resource Center, a Topeka, Kansas-based nonprofit that works to help Gulf War veterans better understand the health issues they face and help them gain VA benefits.

Bunker also served as an artilleryman in Iraq; he's been classified as 100 percent disabled after experiencing a variety of debilitating symptoms including headaches, cramps and convulsions. He got those ailments after a massive Iraqi ammo dump was blown up, not far from where he was at.

Bunker knows the environment in which Kerksieck and other veterans fought their war. They all were exposed to a wide variety of toxins.

"He was exposed to a lot of oil well particulates," Bunker said. "We were drenched in oil. We inhaled oil into our lungs. It soaked into our skin. It got into our food; we were eating it."

Crude oil is steeped in benzine, which is known to "cause a wide variety of cancers," Bunker said. "But this is complicated and hard to prove."

Rod Kerksieck weighed a solid 211 pounds before diagnosed with colon cancer. He now weighs about 165. (Photo: Courtesy of Rod Kerksieck)

Coming home

It was a strange experience, being back from the war, Kerksieck said.

Post-traumatic stress disorder wasn't receiving the attention it does now, and he's not sure if he had PTSD. But he was haunted by the visions of the killing. And he worked his way through the stress by "drinking too much," Kerksieck said.

With Billee's help, and knowing he had children to support, Kerksieck got through it. He went back to the National Guard to finish out his 20 years. After retiring from the military, he kept working. He's had a variety of jobs, but "mostly I was a truck driver," he said.

Around 2005 he noticed chunks of his hair falling out, from his legs and arms and head.

"It would just fall out," Kerksieck said. "For no reason. I'd be standing in the shower, and chunks would just fall off of me."

Medical tests done through Veteran's Affairs in Tomah and Madison failed to find a cause, Kerksieck said. He still doesn't know. He just shrugged it off as one of those things and carried on with his life.

The stomach pain that led to the cancer diagnosis was on another level altogether. He could not shrug that off.

"At first they thought it was diverticulitis (caused by an infection)," Kerksieck said.

Eventually he underwent surgery. "They took a foot of my colon out," he said. "Two weeks later, I get a phone call from my doctor and he told me it was malignant and it was cancer."

For the past two years, Kerksieck has undergone rounds of chemotherapy and other treatments. His weight has plummeted from a strong 211 pounds to 165 pounds. The cancer has spread throughout his body, including his lungs.

"Physically, I'm drained right now. I'm in survival mode," he said.

He's happy the Carbone Cancer Center accepted him for the study. Even if the treatment is unsuccessful, researchers will be able to learn from his ordeal.

But he said, "I've got high hopes. I want my year. That's where my thoughts are right now."

The VA 'refuses to grant those claims'

Bunker, of the National Gulf War Resource Center, said the VA is infamous for declining the Gulf War veterans' disability claims.

The U.S. Government Accountability Office released a study about the VA's response to Gulf War Illness. It found that despite estimates that 44 percent of Gulf War veterans have the medical issues associated with that war, approval rates for Gulf War illness disabilities "were about three times lower than for all other claimed disabilities," the report said.

The review also found that the "VA's ability to accurately process GWI claims is hampered by inadequate training, and its decision letters for denied claims do not communicate key information."

In cases such as Kerksieck's colon cancer, the chances of getting the disability allowance are even less.

Kerksieck knows of one soldier who has late-stage colon cancer who is in hospice.

In Wausau, a younger National Guard veteran who was deployed in the post 9/11 Iraq War is putting his life back together after a couple of years of fighting colon cancer.

Ryan Shilts, 30, served in Iraq guarding prisoners of war in a detainment facility as a National Guardsman. That service did not expose him to oil as it did Kerksieck, but like Kerksieck, Shilts breathed in fumes from "burning pits."

The trash from American soldiers and prisoners were burnt in an area as long as a football field and a few meters wide, Shilts said. It was always burning. Some days the smoke would waft away from the Americans, other days it "was like walking through campfire smoke, all day long."

Shilts doesn't know if that exposure to toxins caused his cancer. "I'm sure it didn't help," he said.

His parents have urged him to file paperwork about his disease to seek disability status. But he knows the odds are against him. He's been through three rounds of cancer treatments that included surgery and radiation and chemo therapies. His scans have been clear, and he's feeling good.

He doesn't want to go through the hassle he knows would be ahead if he tried to claim disability. "I guess I'm just too lazy to do it," he said.

For Billee

Kerksieck is focused on working all the angles of the process. He hopes for a positive outcome, because it would give him peace of mind for Billee, his wife. They've been married for 31 years, and she's supported and stood by him through it all.

"She's been as much of a soldier as I have been," Kerksieck said.

For a while, Kerksieck was getting his insurance through the health care package Billee received from her job at Grassland Dairy Products, the dairy food processor. But she took a leave of absence to care for Kerksieck months ago. The time due her through the federal Family Medical Leave Act ran out, and she was let go, she said.

Billee is now without health insurance and Kerksieck's care comes from the coverage he receives as a veteran. But if he were to gain disability status, he and Billee would receive about $1,200 a month, and as Kerksieck's spouse, she would receive health insurance, too.

Knowing that Billee would be cared for "would give me such peace of mind," Kerksieck said.

That notion motivates him to survive, he said. Even if his efforts to get his disability status don't pan out, he doesn't regret trying. Maybe his efforts will move the system forward for veterans' benefit — and make it easier for others to get placed on disability in the future.

Through it all, Kerksieck remains loyal to the United States and the Army. Even knowing what he knows now, he said he would join again if he had the chance.

"I'm not mad," Kerksieck said. "I just hope that they can learn from this. I don't want another person to go through the living hell what I've gone through."

About 91outcomes

91outcomes.com is a health and news website for veterans of the 1991 Gulf War.

The health outcomes of the 1991 Gulf War continue to profoundly affect between one-fourth and one-third, according to official estimates, of the war’s nearly 700,000 U.S. veterans.

They also affect innumerable fellow veterans from our Coalition partners, including the UK, Australia, Canada, and the Czech Republic, to name just a few.

The aim of 91outcomes.com is to provide fellow Gulf War veterans and their caregivers, advocates, and loved ones, with a credible source of information for health information on Gulf War Illness and other news, all in one place, some of which isn't available anywhere else.

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About Me

Allow me to introduce myself. I'm Anthony Hardie, the publisher and editor of 91outcomes.com. I created 91outcomes.com in 2009** because I'm also one of the 250,000 veterans of the 1991 Gulf War afflicted by Gulf War Illness, and this is what I choose to do to help my fellow Gulf War veterans. Of course, there's much more that remains to be done -- please feel free to jump in and help however you may see fit to fill those many gaps.

I've been continuously active as a national advocate on Gulf War and other veterans' issues since 1995, shortly after my honorable discharge after seven years of U.S. Army service that included serving in the 1991 Gulf War and Somalia. Later, in part because of that advocacy work, I was selected to be a Congressional aide, and then a veterans’ affairs state agency executive. If you're really interested, you can read more about me on my Google profile.

I also do my best to to help my fellow Gulf War veterans by serving as an affected veteran on the programmatic panel that leads and guides theGulf War Illness Research Program, part of the Congressionally Directed Medical Research Programs (CDMRP). And, I'm a former longtime member of VA's Research Advisory Committee on Gulf War Veterans' Illnesses (RAC) and the VA’s Gulf War Illness [Research] Steering Committee. In my service on these panels, I do my very best to represent the many other ill and affected Gulf War veterans, including the readers of this website.

**NOTE: Much of the content on 91outcomes is "fair use" content archived for personal use and for single-site archival use by other Gulf War veterans. Articles dated prior to 2009 are archival in nature, and are pre-dated concurrent to the time noted in the article.

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Depleted Uranium (DU) in the Gulf

Disclaimer

The content contained herein was not prepared by medical professionals and it is not intended, nor should it be considered, as a substitute for medical advice.

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The material contained herein is general in nature and may not apply to your particular factual or legal circumstances.

Online readers should not act on this information without seeking professional counsel and advice.